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Posts Tagged ‘Denosumab’

URO TODAY: New drugs – still being trialled – are proving effective treatment of prostate cancer bone metastases and prevention of fractures associated with androgen deprivation therapy. READ MORE>

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REUTERS: The US Food and Drug Administration has approved the sale of Amgen Inc’s osteoporosis drug Prolia – denosumab – to help prevent fractures in advanced cancer patients just days after the medicine received European approval. It will cost $US825 per 60 milligram injection. READ MORE>

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NEW ENGLAND JOURNAL OF MEDICINE: A new drug just approved by the FDA for high risk prostate cancer patients suffering bone loss has performed well in a trial.

Denosumab was associated with increased bone mineral density at all sites and a reduction in the incidence of new vertebral fractures among men receiving androgen-deprivation therapy for non-metastatic prostate cancer.

Background: Androgen-deprivation therapy is well-established for treating prostate cancer but is associated with bone loss and an increased risk of fracture.

We investigated the effects of denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor-{kappa}B ligand, on bone mineral density and fractures in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer.

Methods: In this double-blind, multicenter study, we randomly assigned patients to receive denosumab at a dose of 60 mg subcutaneously every 6 months or placebo (734 patients in each group).

The primary end point was percent change in bone mineral density at the lumbar spine at 24 months. Key secondary end points included percent change in bone mineral densities at the femoral neck and total hip at 24 months and at all three sites at 36 months, as well as incidence of new vertebral fractures.

Results: At 24 months, bone mineral density of the lumbar spine had increased by 5.6% in the denosumab group as compared with a loss of 1.0% in the placebo group (P<0.001); significant differences between the two groups were seen at as early as 1 month and sustained through 36 months.

Denosumab therapy was also associated with significant increases in bone mineral density at the total hip, femoral neck, and distal third of the radius at all time points.

Patients who received denosumab had a decreased incidence of new vertebral fractures at 36 months (1.5%, vs. 3.9% with placebo) (relative risk, 0.38; 95% confidence interval, 0.19 to 0.78; P=0.006). Rates of adverse events were similar between the two groups.

Researchers: Matthew R. Smith, M.D., Ph.D., Blair Egerdie, M.D., Narciso Hernández Toriz, M.D., Robert Feldman, M.D., Teuvo L.J. Tammela, M.D., Fred Saad, M.D., Jiri Heracek, M.D., Ph.D., Maciej Szwedowski, M.D., Chunlei Ke, Ph.D., Amy Kupic, M.A., Benjamin Z. Leder, M.D., Carsten Goessl, M.D., for the Denosumab HALT Prostate Cancer Study Group.

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NEW YORK TIMES: Denosumab, a new drug to prevent fractures in men undergoing prostate cancer hormone treatment, is likely to get FDA approval for high risk cases only. READ MORE>

An FDA advisory committee has voted against three of four possible uses for breast and prostate cancer patients whose therapy can weaken bones. The FDA will decide in October.

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